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Jewish lawyers for Actos, Actos Bladder Cancer Helpline

Written by Jewish Lawyer on . Posted in Bad Drugs and Medical Devices

Actos has warnings for Bladder Cancer in type II Diabetics. When the U.S. Food and Drug Administration (FDA) approved Actos, it required Takeda Pharmaceuticals to study its potential for causing Actos bladder cancer in patients, based on earlier studies that had linked the drug to the cancer. In 2010, the FDA began a safety review of Actos after five years of the study by Takeda revealed that patients who took Actos for at least two years had an increased risk of bladder cancer.

What are the Symptoms of Bladder Cancer ?

The  symptoms of bladder cancer include:

  • Blood or blood clots in the urine (hematuria). Hematuria occurs in 8 or 9 out of 10 people who have bladder cancer and is the most common symptom. Usually it is not painful.
  • Pain during urination (dysuria).
  • Urinating small amounts frequently.
  • Frequent (UTIs).or urinary tract infrections

What is the Bladder ?

The bladder is an  organ that stores urine as it is filtered from the kidneys. The flexible bladder wall is made up of three layers, allowing the bladder to expand and contract as needed. 90% of bladder cancers are found in the epithelial lining, the innermost layer of the wall.

Bladder Cancer and Mortality Rate

Bladder Cancer Survival Rates
Stages  Relative 5-years Survival Rate
0  98%
I  88%
II  63%
III  46%
IV  15%

Upon diagnosis of cancer, a patient experiences a range of emotions. While a doctor cannot predict the future, he or she can offer the patient some peace of mind by offering an estimate. It is imperative to understand the figures should a patient choose to make this information known.

FDA Safety Announcement

[6-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

Actos News

The U.S. District Judge F. Dennis Saylor issued an order to unseal a whistleblower case by a former Takeda Pharmaceuticals medical reviewer involving the failure to report bladder cancer and Congestive Heart Failure (CHF) adverse events for the diabetes drug Actos.

The whistleblower is Dr. Helen Ge, a medical doctor and former safety consultant to Takeda’s pharmacovigilance division. Dr. Ge worked to review adverse events and to identify and evaluate potential safety signals for the diabetes drug Actos, the only drug in the same class and competing with GlaxoSmithKline’s Avandia.

Dr. Ge had direct knowledge of the Actos bladder cancer risk and, according to the complaint, encountered resistance from her superiors when she tried to report bladder cancer as related to Actos. Takeda’s adverse event database for Actos held more than 100 bladder cancers reported to the company, but only 72 reported to the FDA, which Dr. Ge referred to as “a serious discrepancy.” Takeda, like other drug companies, is required to update the U.S. Food and Drug Administration’s Adverse Event Reporting System

If you or a loved on has been injured by actos call the Actos Helpline Today.


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